Needle-Free Delivery Option Exclusive to Saizen(R)

[~MaryO~]

http://www.prnewswire.com/cgi-bin/stories....02812461&EDATE=

 

 

Needle-Free Delivery Option Exclusive to Saizen® Available for Patients

 

GENEVA, Switzerland and ROCKLAND, Massachusetts, January 10

/PRNewswire-FirstCall/ -- Serono Inc., the US affiliate of Serono (virt-x:

SEO and NYSE: SRA), announced today the availability of Saizen® [somatropin

(rDNA origin) for injection] for use in the treatment of patients with adult

growth hormone deficiency (AGHD), following its FDA approval.

 

"This new indication for Saizen® represents the evolution of our growth

hormone portfolio and further demonstrates our commitment to the metabolic

franchise," said James Sapirstein, executive vice president of Metabolic

Endocrinology at Serono, Inc. "Patients with AGHD who are treated with

Saizen® therapy can use our easy-to-use drug delivery devices such as

cool.click®, a needle-free device that is preferred by pediatric patients

and is now available for use by adults taking Saizen®."

 

Adult Growth Hormone Deficiency (AGHD) can be effectively treated with

Saizen®. With the U.S. approval, patients who were growth hormone deficient

during childhood and have growth hormone deficiency as an adult, may continue

to use Saizen®. In addition, adult patients who have adult onset growth

hormone deficiency either alone, or associated with multiple hormone

deficiencies, now have access to Saizen® and its line of devices.

 

Saizen® can be administered using a needle-free device, cool.click®,

the only FDA approved needle-free device for the administration of growth

hormone. It can also be administered with a recently launched autoinjector

pen device, one.click®, or by traditional needle and syringe. Serono's

portfolio of innovative devices gives patients the choice they want in growth

hormone delivery.

 

Patients can learn more about Saizen® and Serono's growth hormone

delivery devices by talking with their physician, or by calling Serono

Connections for Growth® toll-free at 1-800-582-7989. The full prescribing

information for Saizen® can be found online at http://www.seronousa.com.

 

About Adult Growth Hormone Deficiency (AGHD)

Growth hormone deficiency can be a significant problem for adults even

though they no longer get taller. AGHD is recognized as a specific clinical

syndrome with numerous physiological consequences, with effects on:

- Changes in body composition, including central obesity;

- Lipids in the blood;

- Muscle strength;

- Bone composition;

- Exercise capacity and energy;

- Cardiovascular risk; and

- Psychological well-being (social isolation and depression).

 

There are also studies indicating that patients with AGHD have an

increased risk of mortality from cardiovascular disease, possibly

attributable to their growth hormone (GH) deficiency.

 

GH deficiency in adults can result from a pituitary or peri-pituitary

tumor or as a direct result of the surgery/radiation used to manage these

conditions. Less commonly, GH deficiency in adults arises from a deficiency

acquired in childhood.

 

About Saizen®

Saizen® [somatropin (rDNA origin) for injection] is a human growth

hormone produced by recombinant DNA technology. The recommended dose for

adults at the start of therapy is .005 mg/kg daily. The dosage may be

increased to not more than .01 mg/kg daily after four weeks depending upon

the patient's tolerance of treatment.

 

Saizen® is indicated for the long-term treatment of children with

growth failure due to inadequate secretion of endogenous growth hormone. It

is indicated for replacement of endogenous growth hormone in adults with

growth hormone deficiency that meets the criteria of adult onset or childhood

onset.

 

In patients with AGHD, the most common adverse events with associated

growth hormone therapy are joint and muscle pain, edema, carpal tunnel

syndrome, and tingling.

 

Growth hormone should be used with caution in patients with insulin

resistance, glucose intolerance, diabetes, hypothyroidism, intracranial

hypertension, and in women who are pregnant or nursing. GH should not be used

in patients with Prader-Willi syndrome who are severely obese or have severe

respiratory impairment; in the presence of active neoplasia; and in patients

with proliferative or preproliferative diabetic retinopathy; or in patients

hospitalized with acute critical illnesses.

 

Full prescribing information for Saizen®, including important safety

information, is available at http://www.seronousa.com.